CN105362237A - 一种注射用盐酸罗沙替丁醋酸酯的制备方法 - Google Patents
一种注射用盐酸罗沙替丁醋酸酯的制备方法 Download PDFInfo
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Abstract
本发明提供的是一种注射用盐酸罗沙替丁醋酸酯的制备方法。以盐酸罗沙替丁醋酸酯为原料，以甘氨酸、甘露醇、亚硫酸钠、依地酸二钠为辅料，配制成药液后经超滤过滤，药液经冷冻干燥制备成冻干制剂。制备成的注射用盐酸罗沙替丁醋酸酯用于由胃溃疡，应激性溃疡，出血性胃炎引起的上消化道出血及麻醉前给药。本发明方法提高了注射用盐酸罗沙替丁醋酸酯溶液的稳定性，在配制、分装以及冻干过程中，注射用盐酸罗沙替丁醋酸酯有关物质明显下降，含量无明显变化，制备的注射用盐酸罗沙替丁醋酸酯制剂在运输和贮存过程中稳定性良好。本发明提供的制备方法工艺简单、能耗低、操作方便，按照本发明的方法得到的产品品质优良，疗效确切，质量稳定。
Description
技术领域
本发明涉及的是一种冻干粉针剂的制备方法，具体地说是一种注射用盐酸罗沙替丁醋酸酯的制备方法。通过该方法制备的注射用盐酸罗沙替丁醋酸酯用于由胃溃疡，应激性溃疡，出血性胃炎引起的上消化道出血及麻醉前给药。
背景技术
消化系统疾病是常见的多发病之一，其中又以消化性溃疡为主，主要是因吸烟、饮酒、情绪紧张、药物刺激引起，根据世界卫生组织(WHO)统计,消化性溃疡发病率约占世界人口10％以上。随着社会的发展，生活节奏加快，胃肠疾病的发病率还有逐年升高的趋势，针对这种情况，开发新的消化系统临床用药就成为了医药工作者的当务之急。
盐酸罗沙替丁醋酸酯是疗效高、副作用少的新一代组胺H2受体拮抗剂，主要用于预防和治疗由于胃酸高分泌状态引起的消化系统疾病，如胃溃疡，十二指肠溃疡，吻合部溃疡，返流性食管炎，急性胃炎，慢性胃炎急性发作。
但盐酸罗沙替丁醋酸酯具有对光不稳定并易水解等特点，常规方法制备的产品非常容易降解，有效期短，不利于保存。而制备成冻干粉针剂，如果辅料种类选择不恰当，或者辅料用量选择不恰当都会严重影响产品的质量。
发明内容
本发明的目的在于提供一种能够有效降低产品水分，保证药品外观，质量稳定，疗效确切的注射用盐酸罗沙替丁醋酸酯。本发明的目的还在于提供一种注射用盐酸罗沙替丁醋酸酯的制备方法。
本发明的目的是这样实现的：
本品为注射用盐酸罗沙替丁醋酸酯冻干制剂，每1000支产品含有盐酸罗沙替丁醋酸酯50～100g、甘氨酸30～50g、甘露醇30～50g、亚硫酸钠0.05～0.10g、依地酸二钠0.05～0.10g。
本发明的注射用盐酸罗沙替丁醋酸酯冻干制剂的制备方法包括下列步骤：
(1)按每1000支产品含有盐酸罗沙替丁醋酸酯50～100g、甘氨酸30～50g、甘露醇30～50g、亚硫酸钠0.05～0.10g、依地酸二钠0.05～0.10g的比例称取盐酸罗沙替丁醋酸酯与甘氨酸、甘露醇、亚硫酸钠、依地酸二钠混匀，向其中加入注射用水1000～2000ml，搅拌使完全溶解，加入活性炭，过滤，脱炭，得体系A；
(2)向体系A中补加注射用水至全量，搅拌均匀,得体系B；
(4)对体系B在100级层流超净室内按无菌操作要求，经超滤过滤，分装于管制抗生素瓶中，加通气胶塞，冷冻干燥后压塞，加铝塑组合盖即得。
本发明通过处方、工艺摸索，筛选出了最佳的处方组成、最合适的过滤方式，确定了注射用盐酸罗沙替丁醋酸酯最佳处方及制备工艺。本品选择了先进的冻干剂型，有力的保证了药品的质量，并且更有利于保存。按照确定的处方工艺制备的样品符合药品标准的各项规定，质量稳定，疗效确切。
本发明提供的是一种注射用盐酸罗沙替丁醋酸酯制备方法。按照本方法制备成的注射用盐酸罗沙替丁醋酸酯用于由胃溃疡，应激性溃疡，出血性胃炎引起的上消化道出血及麻醉前给药。经过动物实验及临床试验证实，本品对上消化道出血等消化系统疾病疗效确切，毒副作用小，具有很高的有效性和安全性，值得临床推广使用，是理想的消化系统用药。
本发明的目的在于提供一种注射用盐酸罗沙替丁醋酸酯的制备方法，通过该方法可以对盐酸罗沙替丁醋酸酯的配制过程进行控制，选用的辅料可以促进水分升华，缩短冻干时间，避免出现分层和萎缩等现象。采用超滤的过滤方式，可以更好的去除杂质，保证产品的质量，大大提高了注射用盐酸罗沙替丁醋酸酯的稳定性，制备所得的产品有关物质更低，质量稳定。本发明方法制备工艺简单，方便可行，重复性好，适合工业化大生产要求。
具体实施方式
下面举例对本发明做更详细地描述。但并不因此将本发明限制在所述的实施例范围之中。
实施例1：
处方：
工艺：
(1)按处方比例称取盐酸罗沙替丁醋酸酯与甘氨酸、甘露醇、亚硫酸钠、依地酸二钠混匀，向其中加入注射用水1000～2000ml，搅拌使完全溶解，加入活性炭，过滤，脱炭，得体系A；
(2)向体系A中补加注射用水至全量，搅拌均匀,得体系B；
(4)对体系B在100级层流超净室内按无菌操作要求，经超滤过滤，分装于管制抗生素瓶中，加通气胶塞，冷冻干燥后压塞，加铝塑组合盖即得。
实施例2：
处方：
工艺：
(1)按处方比例称取盐酸罗沙替丁醋酸酯与甘氨酸、甘露醇、亚硫酸钠、依地酸二钠混匀，向其中加入注射用水1000～2000ml，搅拌使完全溶解，加入活性炭，过滤，脱炭，得体系A；
(2)向体系A中补加注射用水至全量，搅拌均匀,得体系B；
(4)对体系B在100级层流超净室内按无菌操作要求，经超滤过滤，分装于管制抗生素瓶中，加通气胶塞，冷冻干燥后压塞，加铝塑组合盖即得。
实施例3：
处方：
工艺：
(1)按处方比例称取盐酸罗沙替丁醋酸酯与甘氨酸、甘露醇、亚硫酸钠、依地酸二钠混匀，向其中加入注射用水1000～2000ml，搅拌使完全溶解，加入活性炭，过滤，脱炭，得体系A；
(2)向体系A中补加注射用水至全量，搅拌均匀,得体系B；
(4)对体系B在100级层流超净室内按无菌操作要求，经超滤过滤，分装于管制抗生素瓶中，加通气胶塞，冷冻干燥后压塞，加铝塑组合盖即得。
实施例4：
处方：
工艺：
(1)按处方比例称取盐酸罗沙替丁醋酸酯与甘氨酸、甘露醇、亚硫酸钠、依地酸二钠混匀，向其中加入注射用水1000～2000ml，搅拌使完全溶解，加入活性炭，过滤，脱炭，得体系A；
(2)向体系A中补加注射用水至全量，搅拌均匀,得体系B；
(4)对体系B在100级层流超净室内按无菌操作要求，经超滤过滤，分装于管制抗生素瓶中，加通气胶塞，冷冻干燥后压塞，加铝塑组合盖即得。
实施例5：
处方：
工艺：
(1)按处方比例称取盐酸罗沙替丁醋酸酯与甘氨酸、甘露醇、亚硫酸钠、依地酸二钠混匀，向其中加入注射用水1000～2000ml，搅拌使完全溶解，加入活性炭，过滤，脱炭，得体系A；
(2)向体系A中补加注射用水至全量，搅拌均匀,得体系B；
(4)对体系B在100级层流超净室内按无菌操作要求，经超滤过滤，分装于管制抗生素瓶中，加通气胶塞，冷冻干燥后压塞，加铝塑组合盖即得。
实施例6：
处方：
工艺：
(1)按处方比例称取盐酸罗沙替丁醋酸酯与甘氨酸、甘露醇、亚硫酸钠、依地酸二钠混匀，向其中加入注射用水1000～2000ml，搅拌使完全溶解，加入活性炭，过滤，脱炭，得体系A；
(2)向体系A中补加注射用水至全量，搅拌均匀,得体系B；
(4)对体系B在100级层流超净室内按无菌操作要求，经超滤过滤，分装于管制抗生素瓶中，加通气胶塞，冷冻干燥后压塞，加铝塑组合盖即得。
实施例7：
处方：
工艺：
(1)按处方比例称取盐酸罗沙替丁醋酸酯与甘氨酸、甘露醇、亚硫酸钠、依地酸二钠混匀，向其中加入注射用水1000～2000ml，搅拌使完全溶解，加入活性炭，过滤，脱炭，得体系A；
(2)向体系A中补加注射用水至全量，搅拌均匀,得体系B；
(4)对体系B在100级层流超净室内按无菌操作要求，经超滤过滤，分装于管制抗生素瓶中，加通气胶塞，冷冻干燥后压塞，加铝塑组合盖即得。
实施例8：
处方：
工艺：
(1)按处方比例称取盐酸罗沙替丁醋酸酯与甘氨酸、甘露醇、亚硫酸钠、依地酸二钠混匀，向其中加入注射用水1000～2000ml，搅拌使完全溶解，加入活性炭，过滤，脱炭，得体系A；
(2)向体系A中补加注射用水至全量，搅拌均匀,得体系B；
(4)对体系B在100级层流超净室内按无菌操作要求，经超滤过滤，分装于管制抗生素瓶中，加通气胶塞，冷冻干燥后压塞，加铝塑组合盖即得。
实施例9：
按实施例1～8分别制备3批注射用盐酸罗沙替丁醋酸酯，进行检验，详细检验结果见表1。
结果表明：本发明提供了合理稳定的处方及工艺，制备过程中采取了先进的超滤过滤方式，有效控制了杂质限量，提高了产品的品质。制备工艺简单，方便可行，重复性好，适合工业化大生产要求。按此处方及工艺制备的样品经过稳定性考察，证明其性质稳定。
表1
Claims (2)
1.一种注射用盐酸罗沙替丁醋酸酯冻干制剂，其特征是：
每1000支产品含有盐酸罗沙替丁醋酸酯50～100g、甘氨酸30～50g、甘露醇30～50g、亚硫酸钠0.05～0.10g、依地酸二钠0.05～0.10g。
2.一种如权利要求1所述的冻干制剂的制备方法，其特征在于包括下列步骤：
称取处方所需量的盐酸罗沙替丁醋酸酯与各种辅料混合均匀后，加入注射用水，搅拌至完全溶解，调节溶液pH值，补加注射用水至全量，采用超滤的方式过滤，药液分装，冷冻干燥即得。
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